NCT06616480已完成不适用
Multicenter, Open, Parallel, Randomized Controlled Comparison on the Safety and Efficacy Clinical Study of DSFNC1 Soft Hydrophilic Contact Lenses With SiHy Color Soft Hydrophilic Contact Lenses
BenQ Materials Corporation2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2023年3月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Efficacy evaluation indexes
研究概览
简要总结
This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of DSFNC1 soft hydrophilic contact lenses with SiHy color soft hydrophilic contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, gender is not limited;
- •Soft hydrophilic contact lenses to be worn range from 0.00 to -12.00D;
- •Both eyes were normal with no other abnormality or disease other than refractive error;
- •Best-corrected eyesight ≥ 1.0 in both eyes with frame lenses;
- •Astigmatism ≤ 2.0D;
- •T5ar film break-up time (BUT) >5s in both eyes
- •Those who are able to complete a minimum of 90 days of follow-up and are able to wear contact lenses as required by the protocol;
- •Ability to understand the purpose of the trial, to participate voluntarily and to have Informed Consent signed by the subject himself/herself or his/her legal guardian.
排除标准
- •Persons with any systemic condition that contraindicates the wearing of contact lenses, or who are receiving treatment that interferes with vision or the wearing of contact lenses;
- •Those who had worn hard contact lenses within 4 weeks or soft contact lenses within 7 days prior to enrollment in this trial;
- •People who are allergic to contact lens, and people with systemic allergic diseases;
- •Patients with conical corneas or other irregular corneas;
- •Those who have to wear soft hydrophilic contact lenses for a long period of time under special circumstances such as dryness, severe dust or volatile chemicals;
- •Those who are pregnant, breastfeeding, or planning a pregnancy at the time of enrollment;
- •Those who were eligible for enrollment in only one eye;
- •Concurrent participation in other clinical trials or participation in a soft contact lens clinical trial of soft hydrophilic contact lenses within 10 days prior to enrollment in this trial
- •Participants who have participated in a clinical trial of a drug or a medical device other than a contact lens within 3 months prior to enrollment in this trial;
- •Other conditions that, in the judgment of the investigator, make wearing soft contact lenses unsuitable or preclude enrollment.
结局指标
主要结局
Efficacy evaluation indexes
时间窗: after wearing lenses for 7 days
The proportion of contact lens-corrected eyesight, The percentage of changes in iris color
次要结局
- Time of Break up time (BUT)(on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days)
- Distance Uncorrected visual acuity (UCVA)(on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days)
- Fitness of the contact(on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Study to Evaluate the Safety and Efficacy of MSENC1 Soft Hydrophilic Contact Lenses and Oxypure Color Soft Hydrophilic Contact LensesMyopiaNCT06616519BenQ Materials Corporation192
已完成
不适用
Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T2DMType 2 Diabetes MellitusNCT05417841Beijing Hospital218
进行中（未招募）
不适用
STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression FracturesVertebral Compression FractureCompression FractureVertebral CompressionNCT04835428AgNovos Healthcare, LLC408
招募中
不适用
Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGEBrain DiseasesAneurysmIntracranial AneurysmNCT06189950MicroPort NeuroTech Co., Ltd.200
尚未招募
3 期
A Clinical Study Comparing Semaglutide Injection and Wegovy® for Weight Management in Obese SubjectsObesityNCT06738979Chia Tai Tianqing Pharmaceutical Group Co., Ltd.408